Monthly Archives: November 2015

Winter was oddly mild in northern Texas in 2012, a year that saw few snowflakes and barely any ice. When the cold failed to show up, the spring mosquitoes arrived in droves, carrying disease.

The insects multiplied during an unusually muggy May, when temperatures hit the 90s and then stayed there. On June 20, Dallas recorded the season’s first case of West Nile virus. By late August, there were nearly 400.

A matter of degrees: Diplomats are heading to Paris to come up with a plan for averting the worst effects of climate change. Their goal: Keep global temperatures from rising more than two degrees Celsius over preindustrial levels. But are they too late?Part I: The great thawNineteen people would die in the greater Dallas area in the worst West Nile outbreak in U.S. history. The 2012 epidemic alarmed health officials and triggered multiple inquiries into the possible causes. One finding would ring ominously in a region grappling with the impacts of climate change: When it comes to insect-borne disease, warmer is worse.

“With warmer weather, mosquitoes fly more and bite more. And warmth amplifies the infectivity and replication of the virus,” said Robert Haley, director of epidemiology at the University of Texas Southwestern Medical Center and co-author of a major study on the 2012 outbreak. “If everything else stays the same, you could predict that a warmer climate makes things worse.”

Although the US has made significant strides towards improving preparedness for a bioterrorist attack, the nation’s biosurveillance capabilities are a far cry from adequate, according to a recent report by the Government Accountability Office (GAO), which found he nation’s billion dollar biosurveillance detection system can’t be counted on to actually work.

In April, the House Committee on Homeland Security’s Subcommittee on Emergency Preparedness, Response and Communications said a biological terrorist attack on the US is an “urgent and serious threat.”

The US began to recognize a bioterrorist attack as a serious and urgent threat just days after the terrorist attacks of Sept. 11, 2001 when anonymous letters laced with deadly anthrax spores were sent through the mail, sickening 17 people and killing 5 others. The anthrax attacks awakened the nation to the catastrophic impact of a bioterrorist attack in the US.

Shortly thereafter, the Department of Homeland Security (DHS) quickly rolled out a biosurveillance program known as BioWatch to provide early warning of a biological weapon attack in the US. Deployed in more than 30 metropolitan areas throughout the country, the system uses aerosol collectors to detect the intentional release of select aerosolized biological agents.

However, GAO determined the rapid deployment of the program in 2003 did not allow for sufficient testing and evaluation of the system’s capabilities. The report said that without sufficient testing, DHS could not support the claim that the program could meets its operational objective to detect catastrophic attacks, which they define as attacks large enough to cause 10,000 casualties.

“DHS officials told us that in the 12 years since BioWatch’s initial deployment, they have not developed technical performance requirements against which to measure the system’s ability to meet its objective,” GAO stated.

DELRAY BEACH, Fla., Nov. 10, 2015 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID” or “Company”) (OTCQB:PSID), a life sciences company with an extensive patent portfolio, announced today that it has completed a new sample preparation breadboard system which complements, and works in conjunction with the Company’s Firefly Dx polymerase chain reaction (“PCR”) breadboard prototype pathogen detection system (“prototype system”).

The new Firefly Dx prototype system incorporates sample preparation on a disposable injection molded cartridge that removes contaminants and purifies samples for processing and detection with PCR. Including sample preparation on the prototype system is expected to improve the ability to purify the sample and detect the organism of interest at much lower levels.

Firefly Dx is targeting the global PCR market, which is projected to reach approximately $27.4 billion this year, according to a Research and Markets’ report Polymerase Chain Reaction (PCR) – Products/Tools – A Global Market Watch, 2009-2015.

“In addition to having PCR capabilities on the Firefly Dx prototype, we are now at the next iteration of the design, which includes sample prep,” said William J. Caragol, Chairman and CEO of PositiveID. “In a short period of time, we expect to be at a stage of our development where we can take a sample (whole organism), run it through sample prep and purification followed by the real-time optics and PCR testing on one system. That will be a critical milestone in our development as we prepare for field-testing later next year.”

PositiveID’s Firefly Dx is designed to provide real-time, accurate diagnostic results in less than 20 minutes from a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment, highly trained personnel, and can take hours or even days to provide results. Firefly’s applications include point-of-need, lab-quality, detection of pathogenic organisms; agricultural and food screening in both domestic sectors and developing countries; and detection of biological agents associated with weapons of mass destruction.

Based on its latest advancements in the development of the Firefly Dx prototype system, the Company is now running the sample preparation and PCR elements of the development in parallel with the objective of accelerating the completion of a field-testable unit. PositiveID’s goal is to have units available for testing by the end of 2016.

The Company is currently testing its newly designed sample preparation prototype system with injection-molded, single-use, disposable cartridges. The next step in the development of the Firefly Dx prototype system will be to process samples through only the Company’s system, from sample preparation to reporting of results.

The Blue Ribbon Study Panel on Biodefense recently released its report following a year-long study of how America can and should address biological threats – both man-made and naturally occurring. It is substantive, serious and scholarly. It deserves serious attention by policy makers, health practitioners and political pundits.Why, you ask? Because the human health and economic impact of a wide-spread biological “event” is not receiving sufficient attention and, as the report says, current programs are wasting time and money that could be spent in a more effective manner. There is one other reason to take the report seriously. If no action is taken on the Panel’s 33 recommendations, it will serve as the basis of a scathing “after action report” – the kind that plaintiff’s lawyers and congressional oversight investigators use as a guidebook for placing blame. Does anyone really think we need more of that?The Blue Ribbon Study Panel, ably led by Former Governor and DHS Secretary Tom Ridge and Former Senator and Vice Presidential Candidate Joe Lieberman, included former HHS Secretary Donna Shalala, former Senate Majority Leader Tom Daschle, former Representative Jim Greenwood, and former White House Homeland Security Advisor Ken Wainstein. At the report roll-out on October 28, and in Senate testimony that same day, Ridge, Lieberman and Wainstein were effusive about the magnificent staff work performed by Drs. Asha George and Ellen Carlin.

Since the events of 2001, the agricultural sector has made great strides in preparing for challenges posed by a natural or intentional introduction of a biological event. But animal agriculture needs to more closely integrate with the public health sector as the nation is still “woefully underprepared” for the next big threat, according to Dr. Tammy Beckham.

Testifying before a House Agriculture subcommittee Nov. 3, Beckham, dean of the college of veterinary medicine at Kansas State University, said as demonstrated recently during the porcine epidemic diarrhea virus (PEDV) in swine herds, highly pathogenic avian influenza (HPAI) in poultry populations and last the Ebola virus (EBOV) disease in the public health sector, the approach has been mostly reactive and less proactive when it comes to preparing for the next emerging threat.

Beckham said actions must be taken immediately to address gaps in the current biodefense system. In her written testimony she shared that there is increased movement of people, animals, plants and products globally, increasing the potential for disease threats to emerge. It is estimated that on any given day, approximately 1 million swine and 400,000 cattle are in transit to the next location in the production system at any given time during the day.

She shared that during the 2014 Ebola virus outbreak in the U.S. the meaning of the term “One Health” took on a new significance and some of the greatest lessons were learned and largest gaps in biodefense highlighted. The One Health Initiative has the goal of uniting human and veterinarian medicine by expanding interdisciplinary collaborations and communications.

Beckham cited that it has been estimated that over 75% of all emerging pathogens are zoonotic and that zoonotic pathogens are twice as likely to be associated with an emerging disease as non-zoonotic pathogens. She said that as most diseases are zoonotic, it’s important to develop countermeasures that are effective and stamp out the diseases in the animal population before it gets into humans.

“All too often we have been very reactive,” she said. By focusing on preparedness rather than being reactive it is going to require the human health component see the animal health component as just as important.”